# K990958: Orthogonal EP Catheters

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Jun 3, 1999 after 73 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081329: Reprocessed Electrophysiology Catheters (2008), 1 descendant of its own
- K112232: Reprocessed Electrophysiology Catheters (2011), 0 descendants of its own
- K101789: Reprocessed Electrophysiology Diagnostic Catheters (2010), 0 descendants of its own

## Indications for use
The ORTHOGONAL™ Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and His bundle.

Source page: https://510kreport.com/device/K990958
Methodology: https://510kreport.com/methodology